双氯芬酸二乙胺的有关物质测定  

Determination of related substances in diclofenac diethylamine

作　　者：李玮玲[1] 

机构地区：[1]广州市药品检验所,广州510160

出　　处：《药物分析杂志》2013年第9期1546-1550,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立RP-HPLC法测定双氯芬酸二乙胺原料的有关物质。方法:采用Ultimate C18色谱柱(250 mm×4.6 mm,5μm),以甲醇-4%醋酸水溶液(65∶35)为流动相,流速为1 mL·min-1,检测波长254 nm。结果:采用加校正因子的主成分自身稀释方法测定,方法的专属性强,双氯芬酸二乙胺浓度在1.011～20.22μg·mL-1范围内呈线性,线性方程为A=19.30C+0.3945,r=0.9999(n=5);最低检测限为0.50 ng。结论:本方法可用于双氯芬酸二乙胺有关物质的测定。Objective：To establish a RP - HPLC method for the determination of related substances in diclofenac diethylamine. Methods：The test used an Ultimate C 18 column（250 mm × 4. 6 mm,5μm）. The mobile phase con- sisted of methanol -4% acetic acid solution（65： 35） at the flow rate of 1 mL . min-1 , the detection wavelength at 254 nm. Results：The main component self- compared with calibration factor was used to test the related sub- stances. The method was specific. Diclofenac diethylamine had a good linear relationship in the range of 1.011 - 20. 22.g . mL -1, the calibration curve was A = 19. 30C ＋ 0. 3945, r = 0. 9999 （ n = 5 ） and the lowest limit of de- tection was 0. 5 ng. Conclusion：The method is simple, sensitive and rapid and it can be used for the determination of related substances in diclofenac diethylamine.

关 键 词：非甾体抗炎药 双氯芬酸二乙胺 原料 有关物质 校正因子 自身稀释 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]